Shina Med Corp

FDA Filings

This page includes the latest FDA filings for Shina Med Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004458481
• FEI Number: 3004458481
• Name: SHINA MED CORPORATION
• Owner & Operator: SHINA MED CORPORATION
• Contact Address: 455-30, Bogaewonsam-ro Bogae-myeon; Anseong-si KR-41 Gyeonggido 17509 KR
• Official Correspondent:
  • Kye Chae Jung
  • 82-31-80572125-x
• US Agent:
  • Priscilla Chung
  • TNS USA
  • 714 2025789
  • juhee.c@lkconsultinggroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 455-30, Bogaewonsam-ro Bogae-myeon; Anseong-si Gyeonggido, 17509 KR
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 08800052607873 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.5cc 28G 12.7mm	2023-11-15
GUDID 08800052607842 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.3cc 31G 6mm	2023-11-15
GUDID 08800052607811 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.3cc 29G 12.7mm	2023-11-15
GUDID 08800052607781 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.3cc 31G 8mm (HUM)	2023-11-15
GUDID 08800052607750 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.3cc 31G 8mm	2023-11-15
GUDID 08800052607729 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.3cc 30G 12.7mm	2023-11-15
GUDID 08800052607699 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.3cc 30G 8mm	2023-11-15
GUDID 08800052607668 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.5cc 31G 6mm	2023-11-15
GUDID 08800052607637 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.5cc 29G 12.7mm	2023-11-15
GUDID 08800052607606 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.5cc 31G 8mm	2023-11-15
GUDID 08800052607576 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.5cc 30G 12.7mm	2023-11-15
GUDID 08800052607545 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 0.5cc 30G 8mm	2023-11-15
GUDID 08800052607514 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 1.0cc 31G 6mm	2023-11-15
GUDID 08800052607484 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 1.0cc 29G 12.7mm	2023-11-15
GUDID 08800052607453 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 1.0cc 31G 8mm	2023-11-15
GUDID 08800052607422 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 1.0cc 30G 12.7mm	2023-11-15
GUDID 08800052607392 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 1.0cc 30G 8mm	2023-11-15
GUDID 08800052607361 SHINA MED CORPORATION	Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm	2023-11-15
PMN K191531 Shina Med Corporation	Sure-Fine Insulin Syringes	2019-09-06
GUDID 08800052600744 SHINA MED CORPORATION	SureFine Pen Needle 32Gx6mm	2019-05-09
GUDID 08800052600713 SHINA MED CORPORATION	SureFine Pen Needle 32Gx4mm	2019-05-09
GUDID 08800052600683 SHINA MED CORPORATION	SureFine Pen Needle 31Gx8mm	2019-05-09
GUDID 08800052600652 SHINA MED CORPORATION	SureFine Pen Needle 31GX5mm	2019-05-09
GUDID 08800052600621 SHINA MED CORPORATION	SureFine Pen Needle 30Gx8mm	2019-05-09
GUDID 08800052600591 SHINA MED CORPORATION	SureFine Pen Needle 29GX12.7mm	2019-05-09
GUDID 08800052600560 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 1CC31Gx8mm	2019-05-09
GUDID 08800052600522 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 1CC30Gx8mm	2019-05-09
GUDID 08800052600485 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 1CC30Gx12.7mm	2019-05-09
GUDID 08800052600447 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 1CC29Gx12.7mm	2019-05-09
GUDID 08800052600409 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 1CC28Gx12.7mm	2019-05-09
GUDID 08800052600362 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 0.5CC31Gx8mm	2019-05-09
GUDID 08800052600324 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 0.5CC30Gx12.7mm	2019-05-09
GUDID 08800052600287 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 0.5CC30Gx8mm	2019-05-09
GUDID 08800052600249 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 0.5CC29Gx12.7mm	2019-05-09
GUDID 08800052600201 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 0.5CC28Gx12.7mm	2019-05-09
GUDID 08800052600164 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 0.3CC31Gx8mm	2019-05-09
GUDID 08800052600126 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 0.3CC30Gx12.7mm	2019-05-09
GUDID 08800052600089 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 0.3CC30Gx8mm	2019-05-09
GUDID 08800052600041 SHINA MED CORPORATION	Sure-Fine Insulin Syringes 0.3CC 29G 12.7mm	2019-05-08
PMN K080600 | MEG SHINA MED CORPORATION	ULTIMED ULTICARE SAFETY SYRINGE	2016-12-28
PMN K152879 | FMF SHINA MED CORPORATION	Sure-Fine Insulin Syringes	2016-09-20
PMN K152879 SHINA MED CORPORATION	Sure-Fine Insulin Syringes	2016-09-09
PMN K861153 | FMF SHINA MED CORPORATION	DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES	2016-09-01
PMN K103011 | MEG SHINA MED CORPORATION	ULTICARE SAFETY INSULIN SYRINGE	2016-09-01
PMN K103011 | FMI SHINA MED CORPORATION	ULTICARE SAFETY INSULIN SYRINGE	2016-09-01
PMN K103011 | FMF SHINA MED CORPORATION	ULTICARE SAFETY INSULIN SYRINGE	2016-09-01
PMN K062702 | FMI SHINA MED CORPORATION	ULTICARE DISPOSABLE SYRINGES AND NEEDLES	2016-09-01
PMN K062702 | FMF SHINA MED CORPORATION	ULTICARE DISPOSABLE SYRINGES AND NEEDLES	2016-09-01
PMN K152877 | FMI SHINA MED CORPORATION	SureFine Pen Needle	2016-06-28
PMN K152877 SHINA MED CORPORATION	SureFine Pen Needle	2016-06-07
PMN K113186 | FMI SHINA MED CORPORATION	STERILE INSULIN PEN NEEDLE	2016-02-19
PMN K984017 | FMF SHINA MED CORPORATION	ALLISON MEDICAL INSULIN SYRINGE (AMIS)	2015-04-08
PMN K091167 | FMF SHINA MED CORPORATION	SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES	2015-03-30

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090411872	Pusan,South Korea -> Savannah, Georgia	UNI BODY INSULIN SYRINGE SURECOMFORT BRAND	980 CTN
202008147337	Pusan,South Korea -> Savannah, Georgia	UNI-BODY INSULIN SYRINGE -SURECOMFORT BRAND -HEB BRAND XP.O. 8758 XFOR SHINA MED INSULIN SYRINGE K152879 XPRODUCT CODE FMF	884 PCS
2020080114562	Pusan,South Korea -> Savannah, Georgia	UNI-BODY INSULIN SYRINGE -SURECOMFORT BRAND PEN NEEDLE -SURECOMFORT BRAND XP.O. 8757 XFOR SHINA MED INSULIN SYRINGE K152879	1107 PCS
2020073118007	Pusan,South Korea -> Miami, Florida	UNI-BODY INSULIN SYRINGE	20 PKG
2020072325914	Pusan,South Korea -> Savannah, Georgia	UNI BODY INSULIN SYRINGE SURECOMFORT BRAND	804 CTN
2020071417296	Pusan,South Korea -> Savannah, Georgia	UNI-BODY INSULIN SYRINGE -SURECOMFORT BRAND XP.O. 8752 XFOR SHINA MED INSULIN SYRINGE K152879 XPRODUCT CODE FMF XSHINA MEDS FDA REGISTRATION	884 PCS
2020071417297	Pusan,South Korea -> Savannah, Georgia	UNI-BODY INSULIN SYRINGE -SURECOMFORT BRAND -HEB BRAND -VETRIJEC BRAND XP.O. 8753 XFOR SHINA MED INSULIN SYRINGE K152879	884 PCS
2020071417369	Pusan,South Korea -> Savannah, Georgia	UNI-BODY INSULIN SYRINGE -SURECOMFORT BRAND -HEB BRAND -SURECOMFORT BRAND XP.O. 8748 XFOR SHINA MED INSULIN SYRINGE K152879	825 PCS